Johnson, Kimberly R.

Summary Topical steroids are commonly used in treatment of eosinophilic esophagitis (EoE), but currently there is lack of data to clarify most effective regimen. We aimed to study the achievement of histologic remission using the same dose of budesonide in two different delivery formulations. Patients with established EoE treated with pharmacy compounded budesonide capsule or budesonide Rincinol gel (both 3 mg twice daily) were studied retrospectively. Those with pre-treatment and post-treatment histologic assessment were included with main endpoint being histologic remission. 103 patients (62 gel, 41 capsule) were included, with higher rate of histologic remission with gel (84 vs. 59%, P=0.004). A subset of patients in both groups had lack of steroid response (<50% drop in eosinophils) (15% for gel, 32% for capsule). Formulation/delivery vehicle of steroid treatments to esophageal mucosa in EoE appears important for treatment efficacy, with budesonide gel having higher likelihood of histologic remission compared to budesonide capsules in our population. A truly steroid refractory group appears likely in our population. Larger, prospective studies may help clarify best regimen of topical steroids in EoE and may work to identify patients likely to benefit from alternative therapies.

Background: Surviving critical illness often creates a lasting psychological impact, including depression, anxiety, and post-traumatic stress. Memories of frightening and delusional experiences are the largest potentially modifiable risk factor, but currently, there is no proven intervention to improve these inciting factors. Psychological support based on positive suggestion is a psychotherapeutic approach that can be provided even to patients in altered cognitive states and is therefore a viable psychotherapy intervention throughout the ICU stay. Traditional ICU care team members have limited time and training to provide such psychological support to patients. Doulas are trained supportive companions who have been effectively used to provide patient advocacy and emotional support in other clinical settings and may address this need. Our aim was to train and implement a psychological support based on positive suggestion program for the critically ill using doulas, and measure acceptance of this intervention through stakeholder feedback. Methods: Doula training included three objectives: an introduction to ICU practice structure and policies; education about fundamental aspects of critical care conditions and procedures; and didactic and hands-on learning experiences in effective use of psychological support based on positive suggestion in the critically ill. Doulas were evaluated at the end of their training and during subsequent clinical activities using competency-based assessments as well as through survey-based questions and interviews with key stakeholders. Results: The ICU doulas performed psychological support based on positive suggestion on 43 critically ill patients in the ICU setting. Stakeholder feedback from nurses, patients, and patient families was positive. The majority (28/32) of surveyed bedside ICU nurses reported that the doulas’ involvement was helpful for both patients and nurses alike. All interviewed family members offered positive comments about the ICU doula presence and of the 40 patients who recalled the intervention 37 found it comforting. Conclusions: Our program successfully trained two doulas to work effectively in the ICU setting performing patient-centered psychological support based on positive suggestion interventions. Their training improved their skill sets and was reported as beneficial by patients, families, and critical care nursing. This training program offers a proof of concept that could be applied in other medical centers, bringing doulas more commonly into the ICU practice to help humanize the experience for patients, families, and medical teams.

INTRODUCTION: Histologic response rates to steroids for eosinophilic esophagitis (EoE) vary from < 50% to >90% in controlled trials. We have used varied steroid preparations and higher doses than typically used and aimed to study if steroid dose and delivery vehicle might explain the wide variation in response. METHODS: A database of patients with EoE created in our esophageal clinic was reviewed and patients treated with at least an 8 week course of topical steroid therapy and undergoing pre and post-steroid histologic evaluation were included. Histologic remission was defined as eosinophil count < 15/hpf. Symptomatic remission was defined as complete resolution of symptoms and eating an unlimited diet. Endoscopy reports were reviewed. RESULTS: 94 patients were included, 45 on 3 mg budesonide-Rincinol gel twice daily (HBRG), 29 on 3 mg budesonide capsules BID (BC), and 20 on lower doses of BRG (1.5 mg daily to 2 mg BID) (LBRG). 88.5% had dysphagia at time of steroid initiation. Mean eosinophil count before steroids was 58.6/hpf. 38.3% had esophageal dilation just prior to steroids. Average EFERS prior to steroid treatment was 1.8. There were not significant differences between the groups in terms of demographics, initial eosinophil counts, symptoms, visual EoE assessment (EREFS) or dilation rates. Histologic remission rate for HBRG was 82.2% vs 55.1% for all others combined ( P < 0.001), 51.7% for BC ( P = 0.005 vs 3 mg BRG BID), and 60.0% for LBRG ( P = 0.06 vs 3 mg BRG BID). Symptomatic remission was similar between groups, as was change in EREFS and change in eosinophil counts. Non-responders to HBRG had mean decrease in eosinophil count of only 0.3/hpf (vs 53.2/hpf for responders, P < 0.003) and mean change in EREFS of +1.6 (vs −1.1 for responders, P < 0.001). 62.5% of non-responders to HBRG actually had increase in eosinophil count after steroids. Response rate to HBRG at < 5 eos/hpf was 77.8% overall and 94.6% in those achieving remission. CONCLUSION: A higher remission rate achieved with a more viscous steroid preparation compared to other formulations suggests the importance of both dose and esophageal delivery in treatment of EoE. Further, with adequate mucosal delivery and dosing of topical steroids, steroid refractory EoE appears to be uncommon. On the other hand, these results suggest the existence of a small truly steroid refractory group of EoE patients with negligible histologic, symptomatic and endoscopic response to high dose steroids that warrant further investigation.